Phase II Trial of Weekly Docetaxel/Gemcitabine as First-Line Chemotherapy in Patients with Locally Recurrent or Metastatic Breast Cancer

O’Shaughnessy, Joyce; Pluenneke, Robert; Sternberg, Jack J.; Khandelwal, Pankaj; Ilegbodu, D.; Asmar, Lina

doi:10.3816/cbc.2006.n.003

Cited by 18 publications

(14 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Concomitant DG in our trial yielded a TTP of median 7.0 months. Those results compare well with data from a phase II trial of weekly DG as first-line chemotherapy [15]. Mavroudis et al observed similar results: They reported 8.0 months median TTP in anthracycline-pretreated patients; response rates on the other hand were higher when compared to our study (44% vs. 31%).…”

Section: Discussionsupporting

confidence: 77%

“…Naturally, a lower rate of leucopoenia was observed in a study of weekly DG [15], as well as in a trial of DG with GCSF-support [22]. The only major difference in terms of toxicity between the two arms in our trial was an increased rate of grade 3/4 leucopoenia and neutropoenia in the sequential arm.…”

Section: Discussionmentioning

confidence: 69%

“…In a study conducted by O'Shaughnessy et al the combination of capecitabine and docetaxel was found superior over docetaxel alone in terms of overall survival [13]. Regimens using gemcitabine and taxanes yielded similar efficacy, yet less non-haematological side effects were observed, rendering this an attractive combination [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG)

Tomova¹,

Bartsch

Brodowicz

et al. 2009

Breast Cancer Res Treat

View full text Add to dashboard Cite

Docetaxel (D) plus gemcitabine (G) is an active combination in anthracycline pre-treated breast cancer. Impact of sequential administration of these drugs is unclear. This trial aimed to compare concomitant DG with sequential D ? G. Patients were randomised to eight cycles of gemcitabine 1,000 mg/m 2 on days 1 ? 8 plus docetaxel 75 mg/ m 2 on day 8, or 4 cycles of docetaxel 100 mg/m 2 on day 1, followed by four cycles of gemcitabine 1,250 mg/m 2 on days 1 ? 8, in a 21-day schedule. Time to progression (TTP) was defined as primary endpoint; secondary endpoints were overall response rate (ORR), response duration (RD), overall survival (OS) and toxicity. Due to poor recruitment, the trial was terminated after 100 of a pre-planned 430 patients. Patient characteristics were well balanced. No significant difference was observed in terms of TTP, ORR, RD and OS. Grade 3/4 adverse events encompassed leucopoenia (29 vs. 68%, P \ 0.001), neutropoenia (49 vs. 83%, P \ 0.001) and febrile neutropoenia (4 vs. 9%, n.s.), all favouring D ? G. No difference in efficacy was observed between concomitant and sequential treatment. D ? G produced significantly more episodes of haematological toxicity due to the administration of docetaxel at 100 mg/m 2 without GCSFsupport.

show abstract

Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 69%

See 1 more Smart Citation

Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG)

Tomova¹,

Bartsch

Brodowicz

et al. 2009

Breast Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…All disease sites responded to treatment, even if the small sample size precludes any firm conclusion about the relative occurrence of responses according to sites of disease. The median overall survival of 28.7 months is noteworthy, which is longer than that commonly reported with other regimens including docetaxel [4,11,12,13,21,22,23,24]. Treatment appeared to be slightly more active in previously anthracycline-‘exposed’ patients (response rate 50%) in comparison with ‘resistant’ patients (response rate 29%), even if the small sample size precludes any definite conclusion.…”

Section: Discussionmentioning

confidence: 72%

A Phase II Trial of Docetaxel and Vinorelbine in Patients with Advanced Breast Cancer Previously Treated with Anthracyclines

Vici¹,

Lauro²,

Sergi³

et al. 2008

Oncology

View full text Add to dashboard Cite

Background: It was the aim of this study to evaluate the efficacy of docetaxel and vinorelbine combination in well-defined anthracycline-‘exposed’ or -‘resistant’ advanced breast cancer patients. Patients and Methods: A phase II trial was carried out enrolling 43 advanced breast cancer patients, all previously treated with anthracyclines, both in an adjuvant or advanced setting. Docetaxel 75 mg/m² as 1-hour infusion and vinorelbine 25 mg/m² as 30-min infusion were administered on day 1, every 3 weeks. Results: According to an intent-to-treat analysis, the response rate was 37.2% (95% CI 22.8–51.6) in 43 patients, whereas responses were observed in 16 (1 complete response, 15 partial response) out of 39 evaluable patients (41%, 95% CI 25.6–56.5); there were 50% with first-line and 33% with second-line therapy, and 50 and 29% of patients were considered anthracycline ‘exposed’ and ‘resistant’, respectively; responses by estrogen receptor (ER) status were given in 48% (ER positive) and 25% (ER negative), and by HER2 status, in 21% (HER2 positive) and 52% (HER2 negative). Median time to progression and median overall survival were 7.7 and 28.7 months, respectively. Toxicity was generally acceptable, with grade 3 neutropenia encountered in 15 (35%) patients and grade 4 neutropenia in 1 (2%) patient. Neutropenic fever occurred in 7 patients (16%), usually short-lasting. Grade 3 mucositis was encountered in 2 patients (5%). Conclusions: The combination of docetaxel and vinorelbine as a 3-weekly schedule is active and manageable in advanced breast cancer patients previously treated with anthracyclines.

show abstract

“…Several phase II studies have documented that the combination of docetaxel and gemcitabine is an effective option in MBC. The reported overall response rates ranged from 39 to 66% when the combination was administered as first-line chemotherapy [10,11,12], and from 15 to 54% when the combination was administered as second-line or salvage chemotherapy [13, 14]. …”

Section: Discussionmentioning

confidence: 99%

Weekly Docetaxel with or without Gemcitabine as Second-Line Chemotherapy in Paclitaxel-Pretreated Patients with Metastatic Breast Cancer: A Randomized Phase II Study Conducted by the Hellenic Co-Operative Oncology Group

Papadimitriou

Kalofonos²,

Zagouri

et al. 2009

Oncology

View full text Add to dashboard Cite

Objective: A randomized phase II trial was conducted to test whether the addition of gemcitabine to weekly docetaxel could improve the objective response rate and survival outcomes as second-line chemotherapy in patients with metastatic breast cancer who have failed a paclitaxel-containing regimen. Methods: Patients were randomized to receive either weekly docetaxel 40 mg/m² (group A, n = 34) or the combination of weekly docetaxel 35 mg/m² with gemcitabine 600 mg/m² (group B, n = 41). Three consecutive weekly infusions followed by a 1-week rest period represented 1 chemotherapy cycle. Results: The objective response rate was 18% and 27.5% in group A and B, respectively (p = 0.413). No statistically significant differences were demonstrated in terms of median overall survival and time to disease progression. The rate and grade 3 and 4 neutropenia were higher in group B (23 vs. 3%). Conclusions: The weekly administration of docetaxel and gemcitabine did not result in superior clinical outcomes over weekly docetaxel.

show abstract

Phase II Trial of Weekly Docetaxel/Gemcitabine as First-Line Chemotherapy in Patients with Locally Recurrent or Metastatic Breast Cancer

Cited by 18 publications

References 17 publications

Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG)

Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG)

A Phase II Trial of Docetaxel and Vinorelbine in Patients with Advanced Breast Cancer Previously Treated with Anthracyclines

Weekly Docetaxel with or without Gemcitabine as Second-Line Chemotherapy in Paclitaxel-Pretreated Patients with Metastatic Breast Cancer: A Randomized Phase II Study Conducted by the Hellenic Co-Operative Oncology Group

Contact Info

Product

Resources

About